October 14, 2020
Ra Medical Systems Continues Pivotal Atherectomy Clinical Trial of DABRA System
October 14, 2020—Ra Medical Systems, Inc. announced the resumption of its pivotal clinical trial evaluating the safety and effectiveness of the DABRA excimer laser system as an atherectomy device for the treatment of peripheral artery disease (PAD). The tenth patient in the trial has been enrolled.
The commencement of the trial was announced by the company in February 2020 but enrollment was paused due to the COVID-19 pandemic.
Will McGuire, CEO of Ra Medical Systems, explained in the company’s announcement, “Patient screening and enrollment have recently increased with five clinical sites now cleared to enroll subjects as we pursue an atherectomy indication for DABRA. Earlier this year enrollment in this trial had stalled due to the COVID-19 pandemic, which also impacted our ability to activate new clinical sites. We are pleased that nine subjects have been enrolled in the past 2 months at our clinical study sites, all of which are operating via applicable COVID-19 protocols.”
The open-label pivotal atherectomy clinical trial can enroll up to 100 patients with symptoms of PAD (Rutherford class 2-5) at up to 10 sites. Outcome measures include safety, acute technical success, and clinical success. The trial’s primary efficacy endpoint is the mean reduction in percent diameter stenosis in each patient’s primary lesion as measured by angiography immediately following treatment with DABRA before any adjunctive treatment. The trial’s safety and clinical success endpoints are major adverse events at 30 days and incidence of primary target lesion revascularization at 6 months.
In May 2017, the DABRA excimer laser system received FDA 510(k) clearance for crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease with the intended use for ablating a channel in occlusive peripheral vascular disease.